Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
NCT ID: NCT00958152
Last Updated: 2010-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Cohort 1
VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Cohort 2
VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Cohort 3
VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Interventions
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VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight \> 50 kg
Exclusion Criteria
* Subjects positive for Hepatitis B, Hepatitis C, or HIV
* Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
18 Years
55 Years
ALL
Yes
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Vertex Pharmaceuticals Incorporated
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Christchurch, , New Zealand
Countries
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Other Identifiers
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VX09-222-002
Identifier Type: -
Identifier Source: org_study_id
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